MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 4; CEMENTLESS STEM

Model Number	01.12.024
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 june 2020: lot 145664: (b)(4) items manufactured and released on 20-oct-2014.Expiration date: 2019-09-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event since 2016.Additional implants involved in the event, batch review performed by regulatory affairs department on 17 june 2020: cup: versafitcup cc trio 01.26.45.1154 acetabular shell cc trio no-hole 54 (k122911) lot.143350.Lot 143350: (b)(4) items manufactured and released on 22-jul-2014.Expiration date: 2019-06-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event since 2016.Liner: versafitcup cc trio 01.26.3244hct flat pe hc liner 32 / e (k103352) lot.144768.Lot 144768: (b)(4) items manufactured and released on 24-sep-2014.Expiration date: 2019-08-31.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event since 2016.Implants from ceramtec 38.49.7175.685.00 biolox delta ceramic ball head 12/14 32 size l +4 lot.7010866337 (item not registered in usa).The quality documents (including the sterilization certificates) show that the values obtained in the ball head were according to the specification valid at the time of production.The component properties and microstructure as obtained from the quality documents fulfill the requirements as specified at the time of production.There are no indications of any pre-existing material defect or non-conformities regarding sterilization.
Event or Problem Description
The patient has pain on the femur side and the spect-ct shows red colours on the femoral stem.The patient has an allergy of titanium, reason why the surgeon must revise the all prosthesis.Samples taken during the revision surgery showed an infection.The revision surgery was successfully performed.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 4
• Common Device Name: CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; CH 6874
• MDR Report Key: 10167002
• Report Number: 3005180920-2020-00339
• Device Sequence Number: 2152426
• Product Code: JDI
• UDI-Device Identifier: 07630030802058
• UDI-Public: 07630030802058
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: 01.12.024
• Device Catalogue Number: 01.12.024
• Device Lot Number: 145664
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2020
• Initial Report FDA Received Date: 06/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention